Medical systems, devices, and related methods

ABSTRACT

A medical system includes an insertion device including a delivery shaft with an internal lumen, a coupling tube coupled to the delivery shaft and configured to receive a medical device, and a liner tube inserted through the internal lumen of the delivery shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 17/029,401, filed Sep. 23, 2020, which claims thebenefit of priority under 35 U.S.C. § 119 to U.S. Provisional PatentApplication No. 62/783,034, filed Dec. 20, 2018, which is hereinincorporated by reference in its entirety.

TECHNICAL FIELD

Various aspects of the present disclosure relate generally to systems,devices, and methods useful in medical procedures. More specifically,the present disclosure relates to systems, devices, and methods forperforming a laser lithotripsy procedure with stone dusting.

BACKGROUND

Lithotripsy is a medical procedure involving the physical disruption ofa hardened mass within a body cavity, such as kidney stones, gallstones,pancreatic stones, or the like. In such procedures, energy is applied tothe hardened mass. Different energy sources may be used, such aselectric, hydraulic, laser, mechanical, ultrasound, or the like. Laserlithotripsy is based on the fact that pulsed light energy from an energydelivery device may be converted into a mechanical energy in the form ofa cavitation bubble associated with the occurrence of a shock-wave. Thismechanical energy may help to disrupt and break up the hardened mass.

Many lithotripsy procedures generate particles or pollution within thebody cavity as the hardened mass is disrupted and broken up. Forstone-like masses, these particles may be referred to as “stone dust.”In laser lithography procedures, this stone dust may hindervisualization of the mass, which may prevent the physician from locatingthe mass and delivering the laser energy in the most efficient manner.Fluid may be injected into the body cavity so that a portion of thestone dust will naturally drain out of the body cavity with the fluid.Stone dust or other particles may not drain out of certain body cavitiesor portions of a body cavity, for example, a lower pole of a kidney.Suction may be delivered to the body cavity to help remove the stonedust, but applying suction may require either removing the energydelivery device or inserting an additional medical device into the bodycavity, which may prolong the procedure or expose the patient tocontamination or other risks. Furthermore, the suction device may besusceptible to clogs or reduced fluid flow if stone dust or otherparticles accumulate within the suction lumen. The aforementioned risksmay increase the cost, time, and necessary personnel for a medicalprocedure, further complicating and prolonging the procedure, andexposing the patient to greater risk.

The systems, devices, and methods of the current disclosure may rectifysome of the deficiencies described above, and/or address other aspectsof the prior art.

SUMMARY

Examples of the present disclosure relate to, among other things,medical systems, devices, and methods. Each of the examples disclosedherein may include one or more of the features described in connectionwith any of the other disclosed examples.

In one example, a medical system may include an insertion deviceincluding a delivery shaft with an internal lumen, a coupling tubecoupled to the delivery shaft and configured to receive a medicaldevice, and a liner tube inserted through the internal lumen of thedelivery shaft.

The medical system may further include one or more of the followingfeatures. The coupling tube may include a collapsed configuration and anexpanded configuration. The coupling tube may be configured totransition to the expanded configuration upon receiving the medicaldevice, and the coupling tube may be configured to transition to theexpanded configuration during delivery of a fluid and to transition tothe collapsed configuration during delivery of suction. The couplingtube may be coupled to the delivery shaft via a fitting. A proximal endof the coupling tube may be coupled to a coupling tube plunger, and thefitting may include a fitting housing with a spring biasing the couplingtube plunger. The fitting housing may include a slot, and the couplingtube plunger may include a pin configured to move within the slot.

The medical system may further include an adaptor coupled to a proximalend of the coupling tube plunger, and the adaptor may be configured toform a one-way seal around the medical device. A distal end of thecoupling tube may include a distal flap, and the medical system mayfurther include a loop surrounding a distal portion of the deliveryshaft and the distal flap. The medical system may further include one ormore loops surrounding one or more portions of the delivery shaft andthe coupling tube, and the loops may be formed of a heat-shrink orelastic material. A distal end of the coupling tube may include a skivedportion and a distal portion. The distal portion of the coupling tubemay be coupled to a tube insert, and the tube insert may be positionedwithin a distal opening of the delivery shaft.

The medical system may further include a tube insert positioned withinthe distal portion of the coupling tube, and the tube insert may be morerigid than the coupling tube. The insertion device may include a port,and the liner tube may be inserted through and coupled to the port via aconnector that forms a seal around the port. The connector may include aliner tube plunger and a liner tube plunger housing. The liner tubeplunger may be longitudinally movable within at least a portion of theliner tube plunger housing. The liner tube plunger housing may include aspring biasing the liner tube plunger. The liner tube plunger housingmay include a track, and the liner tube plunger may include a pinconfigured to move within the track. The track in the liner tube plungerhousing may include a longitudinally extending channel with one or moreslots extending from the channel. The medical system may further includea stylet configured to extend through at least a portion of the linertube.

In another aspect, a medical system may include an insertion deviceincluding a delivery shaft with an internal lumen and a coupling tubecoupled to the delivery shaft. The coupling tube may be configured toreceive a medical device, and may be configured to transition between acollapsed configuration and an expanded configuration upon receiving themedical device. The coupling tube may be coupled to an exterior of thedelivery shaft.

The medical system may further include one or more the followingfeatures. The coupling tube may be coupled to the delivery shaft via afitting. A proximal end of the coupling tube may be coupled to acoupling tube plunger. The fitting may include a fitting housing with aspring biasing the coupling tube plunger, and the fitting housing mayinclude a slot. The coupling tube plunger may include a pin configuredto move within the slot.

A distal end of the coupling tube may include a skived portion and adistal portion. The medical system may further include a tube insert,and the tube insert may be more rigid than the coupling tube. The distalportion of the coupling tube may be coupled to the tube insert, and thetube insert may be positioned within a distal opening of the deliveryshaft.

In a further example, a method may include inserting a delivery shaft ofan insertion device and a coupling tube to a treatment site. Thecoupling tube may be coupled to an exterior of the delivery shaft of theinsertion device, and the coupling tube may be in a collapsedconfiguration during insertion. The method may further include insertinga liner tube through a lumen in the delivery shaft via a port in ahandle of the insertion device, and inserting a medical device throughthe coupling tube. Inserting the medical device through the couplingtube may transition the coupling tube from the collapsed configurationto an expanded configuration with a lumen that at least partiallysurrounds the medical device. The method may then include deliveringenergy through the medical device to break up a kidney stone or ahardened mass, and delivering fluid through the lumen of the couplingtube. The method may also include applying suction through the linertube, and breaking up a clog or blockage that forms within the lumen ofthe delivery shaft or within the liner tube.

The method may include one or more of the following features. The stepof breaking up the clog or blockage that forms within the lumen of thedelivery shaft or within the liner tube may include at least one ofextending the liner tube distally via a plunger coupled to a handle ofthe insertion device, or extending a shaft of a stylet through the linertube.

Both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the features, as claimed. As used herein, the terms “comprises,”“comprising,” “having,” including,” or other variations thereof, areintended to cover a non-exclusive inclusion such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements, but may include other elements not expressly listedor inherent to such a process, method, article, or apparatus.Additionally, the term “exemplary” is used herein in the sense of“example,” rather than “ideal.” As used herein, the terms “about,”“substantially,” “generally,” and “approximately,” indicate a range ofvalues within +/−10% of a stated value.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various exemplary embodiments andtogether with the description, serve to explain the principles of thedisclosure.

FIG. 1 is a partially exploded view of a medical system according toaspects of the present disclosure.

FIG. 2 illustrates a portion of the medical system of FIG. 1 , accordingto aspects of the present disclosure.

FIG. 3 illustrates another portion of the medical system of FIG. 1 ,according to aspects of the present disclosure.

FIGS. 4A and 4B illustrate cross-sectional views of a coupling tube in acollapsed and an expanded configuration, according to aspects of thepresent disclosure.

FIGS. 5A and 5B illustrate a distal end of the coupling tube in anisolated view and as coupled to the distal end of the medical system,according to aspects of the present disclosure.

FIGS. 6A-6C illustrate a distal end of an additional coupling tube andmechanisms that may be used to couple the distal end of the additionalcoupling tube to the distal end of the medical system, and FIG. 6Dillustrates another distal end of the additional coupling tube andmechanism that may be used to couple the distal end of the additionalcoupling tube to the distal end of the medical system, according toaspects of the present disclosure.

FIG. 7 provides a flowchart depicting an exemplary method for breakingup and removing a hardened mass from a body cavity, according to aspectsof the present disclosure.

DETAILED DESCRIPTION

Examples of the present disclosure include systems, devices, and methodsto facilitate and improve the efficacy, efficiency, and safety ofmedical procedures to break up and remove hardened masses. For example,aspects of the present disclosure may provide an operator (e.g., aphysician, medical technician, or other medical service provider) withthe ability to more easily apply laser energy from an energy source to akidney stone and apply suction to remove stone dust. Aspects of thepresent disclosure may allow an operator to deliver energy, deliverirrigation, and apply suction within a body cavity, and breakup a clogor blockage within the suction tube without the need to remove medicaldevices from the body cavity. Some aspects of the present disclosure maybe used in performing an endoscopic, hysteroscopic, or ureteroscopicprocedure.

Reference will now be made in detail to examples of the presentdisclosure described above and illustrated in the accompanying drawings.Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

The terms “proximal” and “distal” are used herein to refer to therelative positions of the components of an exemplary medical device oran insertion device. When used herein, “proximal” refers to a positionrelatively closer to the exterior of the body or closer to an operatorusing the medical device or insertion device. In contrast, “distal”refers to a position relatively farther away from the operator using themedical device or insertion device, or closer to the interior of thebody.

FIG. 1 illustrates a medical system 10 that includes an insertion device12, a liner tube 14, and a medical device 16. Insertion device 12 mayinclude a body 18 and a delivery shaft 20. Body 18 may include adeflection lever 22 and at least one port 24. Liner tube 14 may beinserted through port 24 and through delivery shaft 20. Liner tube 14may be coupled to port 24 via a connector 26, which may include plunger28. A proximal end of medical device 16 may be coupled to an energysource (not shown) or to another medical device. A distal end of medicaldevice 16 may be coupled to insertion device 12 via a fitting 30 and acoupling tube 32. Fitting 30 may partially surround a portion ofdelivery shaft 20 or may otherwise be coupled to insertion device 12.Coupling tube 32 may extend distally from fitting 30 and may be coupledto delivery shaft 20 such that medical device 16 may extend throughcoupling tube 32 and be substantially parallel to delivery shaft 20.Medical system 10 may include a stylet 34, which may be inserted throughliner tube 14. Additionally, medical system 10 may include a sealadaptor 36, which may help couple medical device 16 to coupling tube 32.

Insertion device 12 may be a ureteroscope (e.g., LithoVue™ Single-UseDigital Flexible Ureteroscope by Boston Scientific Corp.), an endoscope,a hysteroscope, a bronchoscope, a cystoscope, or any similar device.Insertion device 12 may be for single-use and be disposable, orinsertion device 12 may be reusable. The body 18 of insertion device 12may have a distal portion 38, an intermediate portion 40, and a proximalportion 42. Deflection lever 22 may be positioned on a rounded corner ofproximal portion 42 and be manipulated to deflect a distal end 44 of thedelivery shaft 20. Intermediate portion 40 may be generally a constantdiameter, and may form a portion of the insertion device 12 that anoperator may grip such that the operator's thumb is proximate thedeflection lever 22. The at least one port 24 may be positioned in thedistal portion 38. The at least one port 24 may be a T-connector asshown in FIG. 1 , may be a Y-connector, or another appropriateconnector. Port 24 may be threaded, may be a luer component, and/or mayinclude one or more internal flexible seals. The at least one port 24may connect to the delivery shaft 20 through at least one internal lumen(not shown) in the body 18 of insertion device 12. Additionally,connector 26 may include an external or internal fitting, such as, forexample, a gateway fitting, that may form a seal over port 24 and aroundliner tube 14.

Insertion device 12 includes an internal lumen with a distal opening 46in the distal end 44 that connects to port 24 to form a working channel.As such, liner tube 14 may be inserted through port 24 and extended to aposition just proximal to distal opening 46, or liner tube 14 may beextended distally beyond distal opening 46. Delivery shaft 20 mayinclude an integral camera and/or an illumination source 48 at distalend 44, and camera and/or illumination source 48 may be connected to auser interface and a display via a communication and power conduit 50extending from body 18 of insertion device 12.

Liner tube 14 may be coupled to port 24 via connector 26, and may extendthrough an internal lumen of insertion device 12 such that a distal endof liner tube 14 is approximately flush with or just proximal to distalend 44 of delivery shaft 20. A proximal end of liner tube 14 may becoupled to plunger 28. The proximal end of liner tube 14 may be coupledto a distal end of a plunger body 52 to form a watertight seal aroundthe coupling to allow fluid or material to flow through liner tube 14into a hollow inner portion of plunger body 52. Plunger body 52 mayinclude a plunger hub 54 at a proximal end. In one aspect, plunger hub54 may be coupled to a suction source (not shown) in order to providesuction through liner tube 14 and remove stone dust, other particulate,or fluid from the body cavity. Plunger body 52 may be partiallysurrounded by a plunger housing 56, and plunger housing 56 may extendproximally from connector 26. Plunger housing 56 may include a spring 58between a distal end of plunger body 52 and connector 26 in order tobias movement of plunger body 52 within plunger housing 56. Accordingly,movement of plunger body 52 within plunger housing 56 may extend orretract liner tube 14 relative to distal end 44.

As shown in FIG. 2 , plunger body 52 may include a pin 60, and plungerhousing 56 may include a pin track 62. Pin 60 may be moveable within apin track 62 during the extension or retraction of plunger body 52relative to plunger housing 56. Pin track 62 may include alongitudinally extending channel 64 with the one or more slots 66extending circumferentially around a portion of plunger housing 56 andperpendicular to channel 64. Plunger body 52 may be depressed distallyor pulled proximally relative to plunger housing 56 in order to move pin60 within channel 64.

Additionally, plunger body 52 may be rotated relative to plunger housing56 in order to position pin 60 in one of slots 66, and thus frictionallysecure the longitudinal position of plunger body 52 and liner tube 14.For example, plunger housing 56 may include a proximal slot 66A in orderto lock plunger body 52, and thus liner tube 14, in a proximal orretracted position, which may correspond to the distal end of liner tube14 being proximal of distal end 44 of delivery shaft 20. Plunger housing56 may include one or more distal slots 66B in order to lock plungerbody 52, and thus liner tube 14, in a distal or extended position, whichmay correspond to the distal end of liner tube 14 being distal of distalend 44 of delivery shaft 20. Plunger housing 56 may include one or moreintermediate slots 66C in order to lock plunger body 52, and thus linertube 14, in an intermediate position, which may correspond to the distalend of liner tube 14 being flush with distal end 44 of delivery shaft20.

Liner tube 14 may help to protect the working channel of insertiondevice 12. Additionally, liner tube 14 may be extended distally (viaaction on plunger body 52) in order to help clear or break up clogs thatmay form in distal opening 46 or near distal end 44 of delivery shaft 20during the removal of stone dust. Liner tube 14 may include an outerdiameter that is sized to be received within and be movable within theworking channel of insertion device 12, for example, slightly smallerthan the inner diameter of the working channel. Liner tube 14 may beformed of a thin wall tube, for example, a 0.001 inch thick wall of apolyamide, polytetrafluoroethylene, or another appropriate material. Insome aspects, liner tube 14 or a portion of liner tube 14 may include acoil, braid, or additional layers of material in order to reinforce orstrengthen portions of liner tube 14, for example, a distal end of linertube 14. In other aspects, portions of liner tube 14 may not include thereinforcement or strengthening, which may allow those portions of linertube 14 to be more flexible, for example, in order to deflect withdelivery shaft 20 based on the operator's actuation of deflection lever22.

Furthermore, medical system 10 may include stylet 34. Stylet 34 mayinclude a shaft 68 and a stylet handle 70. Shaft 68 may be sized to fitwithin the inner diameter of liner tube 14, and may be approximately aslong as liner tube 14 and plunger body 52. Shaft 68 may include a distaltip 72, which may be rounded or atraumatic. Stylet handle 70 may besized to fit over, be screwed onto, or otherwise secured to the proximalend of plunger body 52. Stylet 34 may be inserted into liner tube 14 tohelp break up or push out a clog or blockage within liner tube 14, indistal opening 46, or near distal end 44 of delivery shaft 20. Stylethandle 70 may be coupled to plunger body 52 such that shaft 68 extendsthrough at least a portion of liner tube 14 during the insertion ofliner tube 14 through port 24 and delivery shaft 20. Positioning stylet34 within liner tube 14 may add rigidity to liner tube 14, which mayhelp in the insertion. Stylet handle 70 may also help to ensure thatshaft 68 of stylet 34 may be removed from liner tube 14 and plunger 28(after insertion of liner tube 14 or after cleaning/breaking up a clogwithin liner tube 14).

In one aspect, and as shown in FIGS. 1 and 2 , plunger body 52 may be atleast partially transparent. Although not shown, plunger housing 56 mayalso be at least partially transparent. As such, an operator mayvisually observe the relative positioning of plunger body 52 relative toplunger housing 56. The operator may also visually observe the relativeposition of plunger body 52 relative to plunger housing 56 via theposition of pin 60 in pin track 62. Moreover, the operator may visuallyobserve the position of shaft 68 of stylet 34 within both plunger body52 and plunger housing 56, either through one or more partiallytransparent components or via the position of a distal edge of handle 70relative to a proximal edge of plunger hub 54.

Medical device 16 will be described as a laser fiber. However, it isunderstood that medical device 16 may be any type of medical device usedin conjunction with insertion device 12 to delivery medical therapy to atarget site inside a subject. For example, medical device 16 mayalternatively be a retrieval basket, a snare, forceps, and/or a needle.Additionally, although not shown, medical device 16 may include one ormore of a sheath, an insulation layer, a coating layer, etc.

As mentioned, medical device 16 may be coupled to insertion device 12via fitting 30. Medical device 16 may be coupled to a radial exterior ofdelivery shaft 20 via coupling tube 32. For example, as discussed indetail below, coupling tube 32 may include a proximal opening (notshown) and a distal opening 74 (FIG. 1 ) with a lumen extendingtherebetween configured to receive medical device 16. Coupling tube 32may be coupled to delivery shaft 20 via an adhesive, a plurality ofrings of material (e.g., an elastic material, a heat-shrink material,etc.). In one aspect, medical system 10 may include a loop 76 of elasticor heat-shrink material coupled near the distal end of coupling tube 32,such that the distal end of coupling tube 32 may be coupled to deliveryshaft 20.

As shown in FIG. 3 , fitting 30 may include a coupling portion 78 thatmay surround a portion of delivery shaft 20. Fitting 30 may beintegrally formed with insertion device 12, or may be coupled to distalportion 38, for example, via an adhesive, a threaded coupling, afriction fit, etc. Additionally, fitting 30 may include a fitting body80, which may surround a portion of medical device 16. In one aspect, afitting plunger 82 may surround a portion of medical device 16. Forexample, a distal end of fitting plunger 82 may be secured and sealed toa proximal end of coupling tube 32. Fitting plunger 82 may include afitting pin 84, which may be moveable within a fitting track 86. Afitting spring 88 may be positioned within fitting body 80, and may biasthe movement of fitting plunger 82 relative to fitting body 80.Additionally, fitting spring 88 may help coupling tube 32 to flex anddeflect with delivery shaft 20 based on activation of deflection lever22 and/or the insertion or maneuvering of delivery shaft 20 to atreatment site, and may also help coupling tube 32 stay in tension ortake up slack when delivery shaft 20 is in a straight (not flexed ordeflected) condition. In one aspect, coupling tube 32 may also includean extension or loop 76′ of elastic or flexible material coupled to thedistal end of coupling tube 32, and loop 76′ may then be coupled to thedistal end 44 of delivery shaft 20. For example, loop 76′ may fix theposition of the distal end of coupling tube 32 relative to deliveryshaft 20, and as delivery shaft flexes or deflects, fitting plunger 82may move within fitting body 80, as biased by fitting spring 88.Although not shown, fitting track 86 may include one or more slots tolockably position fitting plunger 82 relative to fitting body 80, andthus lockably position coupling tube 32 relative to insertion device 12and delivery shaft 20.

Fitting plunger 82 may be fixed around the portion of medical device 16,and may be moveable within fitting body 80 of fitting 30 to biasedlyextend and retract coupling tube 32 and medical device 16. In anotheraspect, medical device 16 may be longitudinally movable through sealadaptor 36, fitting 30, and coupling tube 32, for example, to extendmedical device 16 distally beyond coupling tube 32 to deliver laserenergy to a kidney stone.

Seal adaptor 36 may be coupled to a proximal end of fitting plunger 82,for example, to a fitting plunger hub 90. Seal adaptor 36 includes anadaptor body 92 with a valve 94, for example, a one-way valve, which mayreceive and form a seal around medical device 16. Seal adaptor 36 alsoincludes an adaptor port 96 and an adaptor tube 98. Adaptor tube 98 maybe coupled to adaptor body 92 at a position distal to valve 94. Medicaldevice 16 may be inserted through seal adaptor 36 and through fittingplunger 82 and coupling adaptor port 96 may be coupled to a fluid source(not shown), and a fluid (e.g., an irrigation fluid, a radiopaque fluid,etc.) may be delivered from the fluid source through adaptor port 96 andadaptor tube 98 and around medical device 16 in coupling tube 32.

In one aspect, and as shown in FIGS. 1 and 3 , one or more of fittingbody 80, fitting plunger 82, and seal adaptor 36 may be at leastpartially transparent. As such, an operator may visually observe therelative positioning of fitting plunger 82 relative to fitting body 80.Additionally, the operator may visually observe the relative positioningof fitting plunger 82 relative to fitting body 80 via the position offitting pin 84 within fitting track 86. Moreover, the operator mayvisually observe the position of medical device 16 within one or more offitting body 80, fitting plunger 82, and seal adaptor 36. The operatormay also visually observe the position of medical device 16 through oneor more visualization units (e.g., a camera) positioned at or withindistal end 44 of delivery shaft 20.

FIGS. 4A and 4B illustrate an alternative example according to thepresent disclosure, with similar elements to medical system 10 shown by100 added to the reference numbers. FIGS. 4A and 4B illustratecross-sectional views of various configurations of coupling tube 132. Asshown in FIG. 4A, coupling tube 132 may include a collapsedconfiguration. In this collapsed configuration, coupling tube 132 mayinclude a collapsed lumen and may be at least partially curved tosurround a portion of delivery shaft 20. For example, coupling tube 132may be in the collapsed configuration and coupled to delivery shaft 20during the insertion and positioning of delivery shaft 20 to thetreatment site.

As shown in FIG. 4B, coupling tube 132 may include an expandedconfiguration. In this expanded configuration, coupling tube 132 may besubstantially ovular or elliptical. Coupling tube 32 may transition tothe expanded configuration upon the insertion of medical device 116within a lumen 101 of coupling tube 132. Additionally, lumen 101 ofcoupling tube 132 may be wider or larger than medical device 116.Accordingly, fluid may be delivered through coupling tube 132 and aroundmedical device 116, as discussed above. Moreover, coupling tube 32 mayinclude an inherent biasing to return to the collapsed configuration(FIG. 4A) when medical device 116 is removed from coupling tube 132.Although the collapsed and expanded configurations of coupling tube 132are shown as curved or partially ovular, this disclosure is not solimited. Coupling tube 132 may take any appropriate shape in thecollapsed and expanded configurations.

FIGS. 5A and 5B illustrate an alternative example according to thepresent disclosure, with similar elements to medical system 10 shown by200 added to the reference numbers. FIGS. 5A and 5B illustrateadditional aspects of coupling tube 232. FIG. 5A illustrates a distalportion of coupling tube 232. In particular, coupling tube 232 mayinclude a distal flap 203. In one aspect, distal flap 203 may be formedby cutting, skiving, or otherwise removing a distal end portion ofcoupling tube 232. Distal flap 203 may then form a substantially flatpiece of material extending from coupling tube 232, and the distal endof coupling tube 232 is open to form distal opening 274 (FIG. 5B), suchthat medical device 16 may extend distally beyond coupling tube 232and/or deliver treatment to the treatment site.

As shown in FIG. 5B, coupling tube 232 may be positioned along andsecured to a distal portion of delivery shaft 220. For example, a loop205 may surround distal flap 203 and delivery shaft 220 near distal end244. Loop 205 may be a ring of material (e.g., an elastic material, aheat-shrink material, etc.). Although loop 205 is shown as a separateelement, in one aspect loop 205 may be integrally formed with couplingtube 232 and distal flap 203.

FIG. 5B also illustrates the extension of liner tube 214 from distal end244 of delivery shaft 220. As discussed above, action on plunger body 52may extend liner tube 214 relative to insertion device 12 and deliveryshaft 220. For example, with suction being delivered through liner tube214, a clog may form at distal opening 46 or near distal end 244 ofdelivery shaft 220. An operator may extend liner tube 214 to break upthe clog or push the clogged material out of distal opening 46.Furthermore, the operator may extend liner tube 214 to apply suction tomaterial or a treatment site distally beyond distal end 244.

FIGS. 6A-6D illustrate alternative examples according to the presentdisclosure, with similar elements to medical system 10 shown by 300added to the reference numbers. In particular, FIGS. 6A-6C illustrate acoupling tube 332 and a mechanism to couple coupling tube 332 to adistal end 344 of delivery shaft 320. FIG. 6A is a side view of couplingtube 332. As shown, coupling tube 332 includes a skived portion 311.Skived portion 311 is proximal to the distal end of coupling tube 332and forms a flap 313. Flap 313 is open along a portion of thelongitudinal length of coupling tube 332. Coupling tube 332 alsoincludes a closed distal portion 315. As shown in FIG. 6A, distalportion 315 may be wider than the proximal portion of coupling tube 332,and flap 313 may transition from the narrower proximal portion ofcoupling tube 332 to the wider distal portion 315. In one aspect, distalportion 315 of coupling tube 332 may be the same diameter as a proximalportion of coupling tube 332, and the proximal portion of coupling tube332 may transition from a flatten or collapsed state to an expandedstate with the same diameter as distal portion 315.

Additionally, a portion of a tube insert 317 may be coupled or otherwisepositioned within distal portion 315. For example, tube insert 317 mayinclude an outer diameter approximately the same size or slightlysmaller than an inner diameter of distal portion 315. Tube insert 317may be more rigid than coupling tube 332. For example, tube insert 317may be formed of a stainless steel hypodermic tube or anotherappropriate material, and may include a wall thickness of approximately0.0025 inches. Although not shown, the outer surface of tube insert 317may be tapered, sand blasted, grooved, textured, barbed, or otherwisemodified to help insert and maintain distal portion 315 and tube insert317 into distal opening 346 at distal end 344 of delivery shaft 320.

In another aspect, distal portion 315 may be cut longitudinally, withthe cut portions positioned around a portion of tube insert 317. In anyof the above aspects, at least distal portion 315 of coupling tube 332may be formed of a heat-shrink material, and may be heat-shrunk around aportion of tube insert 317. Alternatively or additionally, an adhesivemay be used to help couple distal portion 315 and tube insert 317.

As shown in FIG. 6B, flap 313 may be bent approximately 180 degrees. Inthis bent arrangement, distal opening 374 may be approximately alignedwith a distal end (formerly a proximal end) of distal portion 315 andtube insert 317. Distal portion 315 and tube insert 317 may bepositioned within distal opening 346 at distal end 344 of delivery shaft320. In one aspect, an insertion tool 319 may be used to couple distalportion 315 and tube insert 317 into distal opening 346 at distal end344 of delivery shaft 320. It is noted that various aspects of deliveryshaft 320 (e.g., camera and illumination source 48) are omitted forclarity. Insertion tool 319 may include an atraumatic tip and a widerhandle portion. The atraumatic tip may be inserted within tube insert317, and may help securely couple distal portion 315 and tube insert 317within distal opening 346. As shown in FIG. 6C, distal opening 374 maybe aligned with or just proximal to distal opening 346, and couplingtube 332 may be securely coupled to delivery shaft, with tube insert 317helping to secure distal portion 315 within distal opening 346. Althoughnot shown, liner tube 14 and stylet 34 may be inserted through deliveryshaft 320 and may be longitudinally movable through distal opening 346(e.g., radially within distal portion 315 and tube insert 317).Furthermore, one or more loops 76, 205 (FIGS. 1 and 5B) may be used toattach coupling tube 332 to delivery shaft 320, for example, at variouspositions along a longitudinal length of delivery shaft 320.

FIG. 6D illustrates a coupling tube 332 and another mechanism to couplecoupling tube 332 to distal end 344 of delivery shaft 320. FIG. 6D issimilar to FIG. 6C, but with distal portion 315′ being thicker or widerthan distal portion 315. In this embodiment, for example, because distalportion 315′ is thicker or wider than tube insert 317 and distal opening346, only tube insert 317 may be inserted into distal opening 346. Inthis aspect, delivery shaft 320 may maintain a larger inner diameter toallow for a larger liner tube 14 to pass through and remove a greatervolume of fluid or stone dust, larger stones, or a greater amount ofdebris. Furthermore, with distal portion 315′ external to distal opening346, distal portion 315′ may be gripped by the operator to assist inremoving tube insert 317 from distal opening 346. In this example,insertion tool 319 may be used to help couple tube insert 317 withindistal opening, with distal portion 315′ remaining distal to distalopening 346.

FIG. 7 depicts a flow diagram of a method 700 that may be performed withany of the medical devices and systems discussed herein. For example, astep 702 includes attaching coupling tube 32, 132, 232, 332 to deliveryshaft 20, 220, 320. Attaching coupling tube 32 may include one or moreloops 76, 76′, 205 (FIGS. 1, 3, 5A, and 5B) around coupling tube 32,132, 232, 332 (or flap 203) and delivery shaft 20, 220, 320.Alternatively or additionally, step 702 may include distal portion 315and tube insert 317, or only tube insert 317, being coupled withindistal opening 346 (FIGS. 6A-6B). Moreover, step 702 may includecoupling portion 78 of fitting 30 being attached around a portion ofdelivery shaft 20, as discussed above with respect to FIGS. 1 and 3 .

Next, a step 704 includes inserting delivery shaft 20, 220, 320 andcoupling tube 32, 132, 232, 332 to the treatment site. Step 704 mayinclude an insertion guidewire or an other appropriate guidance ordelivery element. As shown in FIG. 4A, coupling tube 132 may be in acollapsed configuration during the insertion (without medical device116) such that coupling tube 132 does not significantly increase across-sectional profile of delivery tube 20, 220, 320 during insertionand positioning. Moreover, an operator may use deflection lever 22 toposition distal end 44, 244, 344 of delivery shaft 20, 220, 320 to thetreatment site. In one aspect, a proximal portion of coupling tube 32,132, 232, 332 is coupled to delivery shaft 20, 220, 320 via fitting 30and spring 88, so coupling tube 32, 132, 232, 332 may deflect withdelivery shaft 20, 220, 320, with a reduced risk of breaking ordisconnecting from delivery shaft 20, 220, 320.

A step 706 includes inserting liner tube 14 through delivery shaft 20.Liner tube 14 may be inserted through port 24, and secured via connector26 and a proximal end of liner tube 14 may be coupled to plunger 52, asdiscussed above. During insertion, shaft 68 of stylet 34 may bepositioned within at least a portion of liner tube 14 for additionalsupport. Once liner tube 14 is inserted within delivery shaft 20 plungerhub 52 may be coupled to a suction source (not shown). Alternatively,step 706 may be performed as part of step 702 before delivery shaft 20and coupling tube 32 are inserted to the treatment site.

In step 708, medical device 16, 116 may be inserted through couplingtube 32, 132, 232, 332. Medical device 16, 116 may be inserted to aposition distal to, aligned with, or proximal to distal end 74, 274, 374of coupling tube 32, 132, 232, 332. Medical device 16, 116 may beinserted through seal adaptor 36 and fitting plunger 82 such that valve94 in adaptor body 92 forms a seal around medical device 16, 116.Additionally, as shown in FIGS. 4A and 4B, inserting medical device 116through coupling tube 132 may expand coupling tube 132 from a collapsedconfiguration to an expanded configuration, which may include lumen 101.

A step 710 includes delivering medical treatment with medical device 16.For example, the proximal end of medical device 16 may be coupled to anenergy source. The distal end of medical device 16 may be extended to bealigned with or extend distally beyond distal opening 74, 274, 374(e.g., by moving fitting plunger 82 relative to fitting body 80), andmay deliver energy to a kidney stone or other hardened mass. Step 710may also include further positioning of distal end 44, 244, 344 in orderto align the delivered energy with the kidney stone or hardened mass,which may include using visualization through camera and/or illuminationsource 48, deflection lever 22, fitting plunger 82, etc.

Next, a step 712 includes delivering fluid through coupling tube 32,132, 232, 332. As discussed above, a fluid source may be coupled toadaptor port 96 such that fluid may be delivered through adaptor tube98, fitting plunger 82, and through coupling tube 32, 132, 232, 332, forexample, through lumen 101. The fluid may be irrigation fluid,radiopaque fluid, etc. The fluid source may be selectively activated(e.g., by a button, foot pedal, etc.), may be a gravity-assistedirrigation bag, or other fluid source, and may help agitate the kidneystone or hardened mass as it is broken up with the energy from medicaldevice 16, 116.

A step 714 includes applying suction through liner tube 14. Asmentioned, the proximal end of plunger body (e.g., plunger hub 54) maybe coupled to a suction source. The suction source may be selectivelyactivated (e.g., by a button, foot pedal, etc.) to remove fluid (e.g.,excess fluid, fluid carrying stone dust, etc.) and pieces of the kidneystone or hardened mass, for example, stone dust. Step 714 may alsoinclude selectively positioning liner tube 14 relative to distal opening46 by positioning pin 60 on plunger 52 in one of slots 66A-66C of pintrack 62.

A step 716 may include breaking up or clearing any clogs or blockagesthat may form in liner tube 14. For example, during step 714 above,stone dust or other particulate matter may collect in distal opening 46and form a clog or blockage. In this aspect, an operator may extendliner tube 14, using plunger 52, distally beyond distal opening 46 tobreak up the clog or blockage or push the clogged material distally outof delivery shaft 20. In another aspect, stone dust or other particulatematter may collect in liner tube 14. In this aspect, shaft 68 of stylet34 may be extended through at least a portion of liner tube 14 to breakup or clear the clog or blockage. In either aspect, suction may then beapplied again, as in step 714, or the operator may deliver energy viamedical device 16, 116 to the material that formed the clog or blockageto further break up the material. Furthermore, the operator may removeliner tube 14 from the working channel of insertion device 12 with theclog retained within liner tube 14. The operator may then attempt toremove the clog from liner tube 14 with liner tube 14 external to thepatient. If successful, the operator may re-insert liner tube 14 intoinsertion device 12. Alternatively, the operator may insert a differentor new liner tube 14 through insertion device 12, or the operator maycontinue the procedure without a liner tube positioned within insertiondevice 12.

Steps 710-716 may be repeated as many times as necessary to break up andremove the kidney stone(s) or other hard material from treatment site.Furthermore, distal end 44, 244, 344 of delivery shaft 20, 220, 320 maybe repositioned (e.g., using deflection lever 22) as many times asnecessary. Once the kidney stone(s) or other material has been removedfrom the treatment site, which may be confirmed via camera and/orillumination source 48 or other methods, the operator may remove medicalsystem 10 from the treatment site.

The systems, devices, and methods discussed herein may help an operatorto quickly and safely deliver medical treatment to a treatment site, forexample, to break up and remove kidney stones or other hard material. Asdiscussed above, once medical system 10 is positioned at the treatmentsite, there is no need to remove insertion device 12 and/or medicaldevice 16 to deliver fluid, apply suction, or otherwise treat thetreatment site. During insertion, coupling tube 32, 132, 232, 332 maynot substantially increase a cross-sectional area of medical system 10,which may reduce the likelihood of injury to the patient, as discussedwith respect to FIGS. 4A and 4B. Additionally, with coupling tube 32,132, 232, 332 coupled to delivery shaft 20 and insertion device 12 viafitting 30 and spring 80, the operator may deflect delivery shaft 20with a reduced risk of disconnecting or interrupting connection tocoupling tube 32. Medical system 10 allows the operator the ability tobreak up clogs or blockages that may form in delivery shaft 20 as aresult of the suction. For example, the operator may extend or retractliner tube 14 using plunger 52, or the operator may insert stylet 34through liner tube 14, without removing delivery shaft 20 or anothercomponent of medical system 10. In some aspects, medical system 10allows the operator to lock positions of plunger body 52 relative toplunger housing 56 or fitting plunger 82 relative to fitting body 80,and thus lock the positions of liner tube 14 and coupling tube 32relative to delivery shaft 20.

While principles of the present disclosure are described herein withreference to illustrative examples for particular applications, itshould be understood that the disclosure is not limited thereto. Thosehaving ordinary skill in the art and access to the teachings providedherein will recognize additional modifications, applications,embodiments, and substitution of equivalents all fall within the scopeof the features described herein. Accordingly, the claimed features arenot to be considered as limited by the foregoing description.

We claim:
 1. A method, comprising: inserting a delivery shaft of aninsertion device and a coupling tube to a treatment site, the couplingtube being coupled to an exterior of the delivery shaft of the insertiondevice, and the coupling tube being in a collapsed configuration duringinsertion; inserting a liner tube through a lumen in the delivery shaftvia a port in a handle of the insertion device; inserting a medicaldevice through the coupling tube, wherein inserting the medical devicethrough the coupling tube transitions the coupling tube from thecollapsed configuration to an expanded configuration with a lumen thatat least partially surrounds the medical device; delivering energythrough the medical device to break up a kidney stone or a hardenedmass; delivering fluid through the lumen of the coupling tube; applyingsuction through the liner tube; and breaking up a clog or blockage thatforms within the lumen of the delivery shaft or within the liner tube.2. The method of claim 1, wherein the step of breaking up the clog orblockage that forms within the lumen of the delivery shaft or within theliner tube includes at least one of: extending the liner tube distallyvia a plunger coupled to a handle of the insertion device; or extendinga shaft of a stylet through the liner tube.
 3. The method of claim 1,comprising coupling the coupling tube is to the delivery shaft via afitting.
 4. The method of claim 3, wherein a coupling tube plunger iscoupled to a proximal end of the coupling tube and wherein the fittingincludes a fitting housing with a spring biasing the coupling tubeplunger.
 5. The method of claim 4, wherein an adapter configured to forma one-way seal around the medical device is coupled to a proximal end ofthe coupling tube plunger.
 6. The method of claim 1, wherein thecoupling tube includes a collapsed configuration and an expandedconfiguration, wherein the coupling tube is configured to transition tothe expanded configuration upon receiving the medical device, andwherein the coupling tube is configured to transition to the expandedconfiguration during delivery of a fluid and to transition to thecollapsed configuration during delivery of suction.
 7. The method ofclaim 1, wherein the fitting housing includes a slot, and wherein thecoupling tube plunger includes a pin configured to move within the slot.8. The method of claim 1, wherein a distal end of the coupling tubeincludes a distal flap, and further including a loop surrounding adistal portion of the delivery shaft and the distal flap.
 8. The methodof claim 1, wherein a distal end of the coupling tube includes a skivedportion and a distal portion, wherein the distal portion of the couplingtube is coupled to a tube insert, and wherein the tube insert ispositioned within a distal opening of the delivery shaft.
 9. The methodof claim 8, wherein the coupling tube comprises a tube insert positionedwithin the distal portion of the coupling tube, wherein the tube insertis more rigid than the coupling tube.
 10. The method of claim 1, whereinthe insertion device includes a port, the method comprising insertingthe liner tube through and coupled to the port via a connector thatforms a seal around the port.
 11. A method comprising: coupling acoupling tube to a delivery shaft of an insertion device; inserting thedelivery shaft of the insertion device to a treatment site inserting amedical device through the coupling tube, wherein inserting the medicaldevice through the coupling tube transitions the coupling tube from acollapsed configuration to an expanded configuration; delivering energythrough the medical device to break up a hardened mass; and
 12. Themethod of claim 11, comprising breaking up a clog or blockage that formswithin a lumen of the delivery shaft.
 13. The method of claim 12,comprising inserting a liner tube through the lumen in the deliveryshaft via a port in a handle of the insertion device.
 14. The method ofclaim 13, comprising extending the liner tube distally via a plungercoupled to the handle of the insertion device to break up the clog orblockage.
 15. The method of claim 13, comprising extending a shaft of astylet through the liner tube to or within the liner tube.
 16. Themethod of claim 13, comprising coupling the coupling tube is to thedelivery shaft via a fitting.
 17. The method of claim 16, wherein acoupling tube plunger is coupled to a proximal end of the coupling tubeand wherein the fitting includes a fitting housing with a spring biasingthe coupling tube plunger.
 18. The method of claim 19, wherein anadapter configured to form a one-way seal around the medical device iscoupled to a proximal end of the coupling tube plunger.
 19. The methodof claim 11, wherein the coupling tube includes a collapsedconfiguration and an expanded configuration, wherein the coupling tubeis configured to transition to the expanded configuration upon receivingthe medical device, and wherein the coupling tube is configured totransition to the expanded configuration during delivery of a fluid andto transition to the collapsed configuration during delivery of suction.20. The method of claim 8, wherein the coupling tube comprises a tubeinsert positioned within the distal portion of the coupling tube,wherein the tube insert is more rigid than the coupling tube.